Incivo (telaprevir)

Incivo tablets contain the active ingredient telaprevir, which is a type of medicine called a protease inhibitor. Telaprevir is an antiviral medicine that is used in combination with ribavirin and peginterferon alfa to treat chronic hepatitis C.

How does it work?

Incivo tablets contain the active ingredient telaprevir, which is a type of medicine called a protease inhibitor. Telaprevir is an antiviral medicine that is used in combination with ribavirin and peginterferon alfa to treat chronic hepatitis C.

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Hepatitis C is a virus that infects the liver and leads to liver damage. Once the virus is inside the liver cells it multiplies, producing numerous copies of its self. An enzyme produced by the hepatitis C virus, called protease, plays an important role in this process. Protease breaks up new protein produced by the virus, so that new copies of the virus can be assembled from the pieces. If this enzyme is stopped from working, any new virus that is produced is faulty and unable to infect more liver cells.

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Protease inhibitors such as telaprevir work by stopping the protease enzyme from working. This lowers the amount of hepatitis C virus in the body and leads to a reduction in liver damage and an improvement in liver function.

Telaprevir must be used in combination with ribavirin and peginterferon alfa to treat chronic hepatitis C. These medicines attack the hepatitis C virus in different ways. If telaprevir is used on its own there is a high chance that the hepatitis C virus will become resistant to it.

How do I take it?

Incivo tablets must be taken with food. They should be swallowed whole with a drink of water and not broken, crushed or chewed.

The usual dose for Incivo tablets is two tablets taken every eight hours (three times a day) or three tablets taken twice a day (a total of six tablets a day). However, it is important that you always follow the instructions given by your doctor.

It is important that these tablets are taken with food and at regular intervals so that effective levels of telaprevir are maintained in the blood.

Incivo tablets should be taken at approximately the same times each day. If you usually take your tablets three times a day and you forget to take a dose, you should take the missed dose with food as soon as you remember, providing it is less than four hours late. Then take the next dose at the usual time. If your missed dose is more than four hours late, then don't take the missed dose. Just take your next dose at the usual time.

If you usually take your tablets twice a day and you forget to take a dose, you should take the missed dose with food as soon as you remember, providing it is less than six hours late. Then take the next dose at the usual time. If your missed dose is more than six hours late, then don't take the missed dose. Just take your next dose at the usual time.

Warning!

Before starting treatment with this medicine you will need to have blood tests to monitor your kidney, liver and thyroid function, as well as the levels of blood cells, haemoglobin, uric acid and electrolytes such as potassium in your blood. These tests will need to be repeated after two, four, eight and twelve weeks of treatment, and then regularly during treatment.

Incivo tablets can cause fainting or affect vision in some people. You should take care when performing potentially hazardous activities, such as driving or operating machinery, until you know how this medicine affects you and are sure you can perform such activities safely.

Incivo treatment is very commonly associated with an itchy rash. This is usually mild or moderate, but in some cases can progress to become severe or involve other areas of the body. You should tell your doctor straight away if you get a rash during treatment, or if you have an existing rash that is getting worse. You should also tell your doctor if you notice any blistering or ulceration on the skin, mouth, eyes or genitals, or if you get a fever, a swollen face or swollen glands with a rash. If your doctor tells you to stop taking Incivo due to a rash, it should not be restarted.

This medicine may decrease the number of blood cells in your blood. Tell your doctor immediately if you experience any of the following symptoms during your treatment, as they may indicate problems with your blood cells: unexplained bruising or bleeding, purple spots, sore mouth or throat, mouth ulcers, high temperature (fever) or other signs of infection, or suddenly feeling tired, breathless, or generally unwell.

The safety and effectiveness of this medicine has not been established in people who have chronic hepatitis C genotypes other than genotype 1.

The safety and effectiveness of this medicine has not been established in people who have had a liver transplant or other organ transplant.

Use with caution in

People with a personal or family history of an abnormal heart rhythm seen on a heart monitoring trace (ECG) as a 'prolonged QT interval'.

People taking medicines that can cause a prolonged QT interval (see end of factsheet for examples).

This medicine is not recommended for people with moderate to severely decreased liver function or decompensated liver disease.

This medicine should not be used if you are allergic to any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy.

If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.

Pregnancy and breastfeeding

Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.

This medicine is used in combination with ribavirin and peginterferon alfa. There is no information available about the use of telaprevir in pregnant women. However, ribavirin may cause serious birth defects and must not be used during pregnancy. For this reason, women will need to have a pregnancy test before treatment with the combination is started. Women having this treatment who could get pregnant must use two effective methods of contraception to prevent pregnancy. You will be given advice on which forms are suitable for you. Non-hormonal methods will be needed while taking telaprevir, because telaprevir can make hormonal methods such as the pill less effective. Contraception should be started before your treatment begins and continued all the time you are taking this combination of medicines. You should continue to use contraception to prevent pregnancy for at least four months after your treatment is finished. You will need to have a pregnancy test every month throughout the treatment and every month for four months after treatment is finished. You should consult your doctor immediately if you think you could be pregnant.

Ribavirin accumulates in sperm and could be harmful to a developing baby. For this reason, men taking telaprevir in combination with ribavirin and peginterferon alfa, or female partners of men taking this medicine with ribavirin and peginterferon alfa, should use effective contraception to avoid pregnancy, both during treatment and for at least seven months after treatment is finished. Men taking ribavirin must also use condoms if their partner is pregnant. See the Rebetol factsheet for more information.

It is not known if this medicine passes into breast milk. However, because the medicine could be harmful to a nursing infant the manufacturer states that women needing treatment with this medicine should not breastfeed. Breastfeeding should be stopped before treatment with this medicine is started. Seek further medical advice from your doctor.

Side effects

Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Just because a side effect is stated here, it does not mean that all people using this medicine will experience that or any side effect.

The side effects listed above may not include all of the side effects reported by the medicine's manufacturer.

Rare (affect between 1 in 1000 and 1 in 10,000 people)

For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.

How can this medicine affect other medicines?

It is important to tell your doctor or pharmacist what medicines you are already taking, including those bought without a prescription and herbal medicines, before you start treatment with this medicine. Similarly, check with your doctor or pharmacist before taking any new medicines while taking this one, to make sure that the combination is safe.

As telaprevir is used in combination with ribavirin and peginterferon alfa, your doctor or pharmacist will also check whether any of your medicines interact with these medicines.

Telaprevir can reduce the breakdown of the following medicines by the body and could therefore increase the risk of serious side effects from these medicines. These medicines must not be used in combination with telaprevir:

alfuzosin

amiodarone

astemizole

atorvastatin

cisapride

disopyramide

dronedarone

ergot derivatives such as dihydroergotamine, ergotamine, ergometrine, and methylergometrine

lovastatin

midazolam or triazolam taken by mouth

pimozide

procainamide

quetiapine

quinidine

sildenafil or tadalafil used for pulmonary arterial hypertension

simvastatin

sotalol

terfenadine.

The following medicines should not be taken in combination with telaprevir, as they decrease the blood level of telaprevir and thus make it less effective against the hepatitis C virus:

carbamazepine

phenobarbital

phenytoin

rifabutin

rifampicin

the herbal remedy St John's wort (Hypericum perforatum).

Telaprevir may increase the blood levels of the following medicines and your doctor may need to monitor treatment with these medicines and adjust doses as necessary:

clarithromycin, erythromycin or telithromycin (these antibiotics may also increase the blood level of telaprevir)

colchicine

dabigatran

digoxin

domperidone (this should be avoided in people taking telaprevir)

fentanyl

fluticasone taken by inhalation or nasal spray

fluvastatin, rosuvastatin or pravastatin

itraconazole, ketoconazole or posaconazole

lidocaine given by injection into a vein for irregular heartbeats

midazolam given by injection

repaglinide

sildenafil, tadalafil or vardenafil for erectile dysfunction

sirolimus

tacrolimus

tenofovir

trazodone.

Telaprevir may affect the blood level of the anticoagulant medicines warfarin and dabigatran and this could change its effect on blood clotting. If you are taking warfarin with this medicine your doctor may want to check your clotting time (INR) more frequently.

Oestrogen-containing contraceptives (eg the pill) may be less effective in women who are taking telaprevir. For this reason, women should use non-hormonal methods of contraception such as condoms to prevent pregnancy while taking this medicine. The effect of telaprevir on hormonal contraceptives lasts for two months after stopping it, so non-hormonal methods should be continued for this time. Condoms should also be used as a regular safe sex practice, to prevent transmitting hepatitis C to your sexual partner. Ask your doctor for further advice.

Oestrogen-based hormone replacement therapy (HRT) may also be less effective in women taking telaprevir.

The following medicines may reduce the blood level of telaprevir and could reduce its effect against the hepatitis C virus; your doctor will want to monitor the levels of virus in your blood if you are prescribed one of these medicines:

bosentan

dexamethasone

efavirenz

protease inhibitors for HIV infection, such as ritonavir, atazanavir, fosamprenavir, lopinavir, darunavir (some of these are not recommended for use with telaprevir).

There may be an increased chance of an abnormal heart rhythm, seen as a 'prolonged QT interval' on an ECG, if this medicine is taken in combination with other medicines that can have this side effect, such as those listed below. The manufacturer states that these medicines should be used with caution in combination with telaprevir:

The materials in this web site are in no way intended to replace the professional medical care, advice, diagnosis or treatment of a doctor. The web site does not have answers to all problems. Answers to specific problems may not apply to everyone. If you notice medical symptoms or feel ill, you should consult your doctor - for further information see our Terms and conditions.